pharmaphorum

JANUARY 10, 2023

Astellas has licensed rights to a drug developed by Selecta Biosciences that could make more patients eligible for treatment with its gene therapy for inherited neuromuscular disorder Pompe disease. The post Astellas licenses companion drug for Pompe gene therapy appeared first on.

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pharmaphorum

DECEMBER 16, 2020

AbbVie is to begin clinical development of an antibody designed to neutralise the SARS-CoV-2 coronavirus after licensing the therapy in from Harbour BioMed and Utrecht University. AbbVie has begun a phase 1 clinical trial of the antibody, with clinical development beginning in the US and expanding into Europe.

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pharmaphorum

SEPTEMBER 27, 2022

While a rumoured takeover by Merck & Co has yet to materialise, Seagen is getting on with its own business development, including a just-agreed licensing deal for a cancer immunotherapy developed by Dutch biotech Lava Therapeutics. The biotech said earlier it planned to seek FDA approval to start clinical trials towards the end of 2022.

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Pharmaceutical Technology

MAY 12, 2023

On 8 May 2023, China-based Bliss Biopharmaceutical (BlissBio) announced a clinical trial collaboration with Eisai to develop BB-1701, an antibody-drug conjugate (ADC) for multiple cancer types. Eisai intends to conduct a Phase II clinical trial for BB-1701 in breast cancer.

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The Pharma Data

JANUARY 11, 2021

a San Diego-based biotechnology company with an array of technology platforms for antibody discovery and optimization, and novel NK and T cell engager generation, today announced licensing of a panel of its anti-SARS-CoV-2 antibody clones to IGM Biosciences for COVID-19 therapy development.

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pharmaphorum

JANUARY 27, 2021

AstraZeneca is playing catch up with Eli Lilly and Regeneron with its antibody therapy for COVID-19, but aims to narrow the gap with the help of decentralised clinical trial specialist Care Access Research. The two antibodies were discovered by Vanderbilt University Medical Center and licensed to AZ in June 2020.

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pharmaphorum

JUNE 17, 2021

Biogen has four other Alzheimer’s candidates in its clinical pipeline behind recently-approved Aduhelm, but one of them – anti-tau antibody gosuranemab – has just been canned. Biogen said it would now focus its efforts on its other tau candidates, headed by BIIB076, which is in phase 1 testing and was in-licensed from Neurimmune.

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XTalks

AUGUST 2, 2024

These trials reveal nemolizumab’s potential to significantly improve key aspects of atopic dermatitis, including skin lesions, itch and sleep disturbance, in both adolescent and adult patients with moderate-to-severe cases. Nemolizumab is a monoclonal antibody that targets IL-31, a cytokine responsible for many atopic dermatitis symptoms.

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Clinical Trials Clinical Trials Trials Licensing 52

XTalks

JULY 25, 2022

Byondis announced that the US Food and Drug Administration (FDA) accepted their Biologics License Application (BLA) for [vic-]trastuzumab duocarmazine (SYD985), an investigational therapy being studied to treat HER2-positive unresectable locally advanced or metastatic breast cancer. Clinical Trial Results for [Vic-]Trastuzumab Duocarmazine

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pharmaphorum

APRIL 14, 2022

Epcoritamab is a bispecific antibody which targets CD3 on white blood cells and CD20 on tumour cells, and is designed to encourage an immune response against the cancer. The two companies are also running a phase 3 trial of the bispecific as a monotherapy in patients with relapsed/refractory diffuse LBCL. billion product at peak.

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Pharmaceutical Technology

AUGUST 8, 2022

The approval was based on findings from the international, randomised, open-label Phase III DESTINY-Breast04 clinical trial. Furthermore, Enhertu’s safety profile was in line with prior clinical trials without any new safety concerns detected. Enhertu-treated subjects had a median overall survival (OS) of 23.4

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pharmaphorum

FEBRUARY 24, 2022

It is currently the only oral small molecule RAGE inhibitor in human clinical trials. According to Cantex, azeliragon has previously been tested for Alzheimer’s disease and diabetic nephropathy, where the drug demonstrated high levels of safety in phase 3 clinical trials involving more than 2,000 patients.

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pharmaphorum

APRIL 9, 2021

The issues are holding up discussions between the agency and company about labeling and post-marketing requirements for teplizumab, and are concentrated around the pharmacokinetics data for the antibody, and whether it is comparable to the drug that its original developer Eli Lilly entered into clinical trials.

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The Pharma Data

NOVEMBER 25, 2020

26, 2020 /PRNewswire/ — Cantargia AB (OMXS: CANTA) and BioInvent International AB (OMXS: BINV), today announced that BioInvent has been contracted as manufacturer of Cantargia’s antibody CAN10 in preclinical development for the treatment of systemic sclerosis and myocarditis. LUND, Sweden , Nov. About Cantargia.

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Pharmaceutical Technology

AUGUST 11, 2022

The proceeds from the business combination will be utilised to advance the pipeline of Disc to clinical trials and offer funding into 2025. They include various patient clinical trials for Disc’s programmes, bitopertin and DISC-0974, which are currently in the clinical development stage.

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pharmaphorum

OCTOBER 18, 2022

Gilead Sciences has made yet another rush into the oncology category, licensing a bispecific antibody from MacroGenics in development as a treatment for CD123-positive blood cancers, including acute myeloid leukaemia (AML) and myelodysplastic syndromes (MDS). It brought in $4.7

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pharmaphorum

MAY 4, 2021

There’s a new biotech on the scene after MoonLake Immunotherapeutics launched on a mission to develop sonelokimab, a potential inflammatory diseases drug in-licensed from Germany’s Merck KGaA. The announcement comes a few days after Merck KGaA’s development partner Avillion announced supportive results in a phase 2 psoriasis trial.

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Pharmaceutical Technology

JUNE 2, 2023

Switzerland-based company Lonza has boosted its antibody-drug conjugates (ADCs) offering with the acquisition of Dutch biotechnology company Synaffix for a total consideration of $172m (€160m). This is expected to streamline the path for ADCs to clinical trial and commercialisation.

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Pfizer

FEBRUARY 16, 2023

These study participants, representing approximately half of the total recruited participants in the trial, are being discontinued following violations of Good Clinical Practice (GCP) at certain clinical trial sites run by a third-party clinical trial site operator.

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Pharmaceutical Technology

DECEMBER 19, 2022

With the latest development, Sanofi will licence a NK cell engager programme that acts on B7H3 from the antibody-based NK cell engager therapeutics (ANKET) platform of Innate. Initially, the companies signed a research collaboration and licensing agreement in 2016 to develop and assess up to two bispecific NK cell engagers.

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The Pharma Data

MARCH 11, 2021

Clinical trial to assess safety, immune response and reactogenicity, after preclinical data showed high neutralizing antibody levels. The Companies expect interim results from this trial in the third quarter of 2021. About the Phase 1/2 clinical trial. About previously-published preclinical results.

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XTalks

JANUARY 29, 2021

Data from Eli Lilly and Company’s (NYSE: LLY) Phase III clinical trial evaluating its monoclonal antibody drugs bamlanivimab (LY-CoV555) and etesevimab (LY-CoV016) show that combining the two significantly reduced the risk of COVID-19 hospitalizations and death by 70 percent. percent) compared with 36 events (7.0

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Pharmaceutical Technology

JULY 29, 2022

The Food and Drug Administration (FDA) has acc epted to review ImmunityBio’s Biologics License Application (BLA) for N-803 to treat Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle-invasive bladder cancer (NMIBC) carcinoma in situ (CIS) patients with or without Ta or T1 disease.

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Trials Clinical Trials Clinical Trials Licensing 264

Pharmaceutical Technology

DECEMBER 28, 2022

Gilead Sciences and Jounce Therapeutics have amended their current license agreement for first-in-class immunotherapy, GS-1811 (formerly JTX-1811). The initial license agreement was signed in 2020. It is currently being evaluated in Phase I clinical trial for the treatment of solid tumours.

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The Pharma Data

JUNE 26, 2021

Sanofi and Translate Bio initiate Phase 1 clinical trial of mRNA influenza vaccine. Th e first clinical trial of a seasonal mRNA flu vaccine candidate is an exciting milestone in our quest for the next generation of inf lu enza vaccines. JUNE 22 , 2021.

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Pharmaceutical Technology

JULY 7, 2022

The US Food and Drug Administration (FDA) has granted priority review to Roche’s Biologics License Application (BLA) of Lunsumio (mosunetuzumab) to treat adults with relapsed or refractory (R/R) follicular lymphoma (FL). The submission is based on positive data from the pivotal Phase I/II GO29781 clinical trial of Lunsumio.

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Pharmaceutical Technology

OCTOBER 25, 2022

Additionally, Astellas will obtain an exclusive option for licencing two clinical-stage programmes of Taysha, namely TSHA-102 and TSHA-120, for Rett syndrome and GAN, respectively. Astellas will also receive specific rights linked to any possible change of Taysha’s control.

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Roots Analysis

FEBRUARY 27, 2024

Currently, product licensing agreements, technology licensing agreements, research and development agreements and clinical trial agreements are the common types of partnerships inked by developers that are currently focused on the development of ADCs pipeline.

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The Pharma Data

AUGUST 20, 2020

Poor regulation of antibodies tests – that could indicate if someone has had coronavirus – could be putting the public at risk, doctors have warned. It is still not known whether having antibodies will protect people from a second infection. Coronavirus infection triggers the immune system to produce antibodies.

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Pharmaceutical Technology

AUGUST 25, 2022

The treatment is indicated for patients with no history of Factor VIII inhibitors and any detectable antibodies to adeno-associated virus serotype 5 (AAV5). The approval is based on comprehensive data from the clinical development programme of Roctavian, including two-year findings from the international Phase III GENEr8-1 clinical trial.

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The Pharma Data

DECEMBER 14, 2020

Harbour BioMed (HBM) announced with Utrecht University on Monday that they have licensed their fully human SARS-CoV-2 neutralizing antibody, 47D11, and its program to AbbVie. AbbVie has initiated a Phase I clinical trial of the antibody, and it will conduct the initial clinical program in the U.S.

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The Pharma Data

JANUARY 6, 2021

a leading global provider of immuno-oncology imaging agents, today announced it has signed a new multi-year, non-exclusive license with Pfizer Inc. Under the terms of the agreement, ImaginAb will supply clinical doses of 89Zr CD8 Immuno-PET agent to Pfizer for use in select oncology clinical trials. LOS ANGELES , Jan.

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The Pharma Data

JANUARY 12, 2021

LONDON, UK / ACCESSWIRE / January 13, 2021 / Hemogenyx Pharmaceuticals plc (LSE:HEMO), the biopharmaceutical group developing new therapies and treatments for blood diseases, is pleased to announce that it has successfully completed the development of its CDX antibody with a leading global pharmaceutical company (“GlobalCo”).

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Pharmaceutical Technology

AUGUST 16, 2022

According to the deal, Horizon will provide the funding to develop the therapy until the conclusion of its two Phase II clinical trials. Under the agreement, Horizon will hold an option for the acquisition of the ADX-914 programme, which is exercisable through a period after concluding the Phase II trials.

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pharmaphorum

NOVEMBER 10, 2021

It is competing in the US with rival oral CGRPs, namely AbbVie’s Qulipta (atogepant) which was approved for episodic migraine prevention in September and AbbVie’s Ubrelvy (ubrogepant) in the acute treatment category, as well as several CGRP-targeting antibodies delivered by injection or infusion from Amgen, Eli Lilly, Teva and Lundbeck.

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The Pharma Data

APRIL 12, 2023

Program uses Denali’s Antibody Transport Vehicle (ATV) technology to cross the blood-brain barrier (BBB) and aims to increase target engagement Biogen Inc. Nasdaq: DNLI) today announced that Biogen has exercised the option to license Denali’s Antibody Transport Vehicle (ATV): Amyloid beta program (ATV:Aβ).

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BioSpace

JANUARY 21, 2021

GSK has discontinued a Phase II clinical trial evaluating an anti-LAG3 cell depleting monoclonal antibody aimed at treating ulcerative colitis licensed from Immutep Limited following an interim assessment of an Independent Data Monitoring Committee.

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